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Medications Lexicon

How does this medication work? What will it do for me?

This combination product contains two medications: tramadol and acetaminophen. Tramadol belongs to a group of medications called opioid analgesics and acetaminophen belongs to a group of medications called analgesics. This combination medication is used to manage moderate to moderately severe pain in adults. It decreases pain by working on the central nervous system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual recommended dose of tramadol - acetaminophen is 1 or 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The tablets can be taken with or without food.

Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each yellow, capsule-shaped, film-coated tablet, engraved "37.5-325" on one side and "APO" on the other, contains 37.5 mg of tramadol hydrochloride and 325 mg of acetaminophen. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, pregelatinized starch, povidone, stearic acid, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, and yellow ferric oxide.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to tramadol, acetaminophen, or any ingredients of the medication
  • are allergic to other opioid medications (e.g., codeine, morphine)
  • are intoxicated with alcohol or other medications such as hypnotics, other opioids such as codeine or morphine, or psychotropic medications (i.e., medications for mental health conditions)
  • are taking or have taken MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide) within the last 14 days

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • headache
  • nausea
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heart beat, weakness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of a severe allergic reaction, e.g.:
    • difficulty breathing
    • hives
    • swelling of the lips, mouth, throat, or tongue
  • signs of a severe skin reaction, e.g.:
    • high fever
    • painful blisters on the skin, mouth, or eyes
    • rash
    • skin peeling off
    • sores

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

July 9, 2015

Health Canada has issued new restrictions concerning the use of acetaminophen. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abdominal conditions: Tramadol - acetaminophen may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing: Tramadol - acetaminophen can suppress breathing. If you have asthma, or are otherwise at risk for breathing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Tramadol can cause physical dependence, psychological dependence, and addiction. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. Do not stop taking this medication without talking to your doctor or pharmacist.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. If you have had a recent head injury, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The kidneys are partially responsible for removing tramadol from the body. People with severely decreased kidney function may experience increased side effects and should not take more than 2 tablets every 12 hours.

If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: The liver is partially responsible for removing tramadol  and acetaminophen from the body. Liver disease or decreased liver function may cause this medication to build up in the body, causing side effects. If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: Tramadol may cause seizures, especially when higher doses are used or when taken with other medications such as:

  • cyclobenzaprine
  • monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
  • neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • opioids (e.g., morphine, codeine, oxycodone)
  • promethazine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine)
  • tricyclic antidepressants (TCAs; e.g., amitriptyline)

The risk of seizures is also higher for people with a history of seizures, or who are at risk of seizures (e.g., people with head trauma). If you have a history of seizures, or are at risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when tramadol is combined with medications used to treat depression. The combination of tramadol and MAO inhibitors must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Surgery: Tramadol may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking tramadol – acetaminophen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used by people under 18 years of age.

Seniors: Seniors may be more likely to experience side effects from this medication. Lower doses may be required.

What other drugs could interact with this medication?

There may be an interaction between tramadol – acetaminophen and any of the following:

  • abiraterone acetate
  • aclidinium
  • alcohol
  • amiodarone
  • aminoglutethimide
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
  • antiseizure medications (e.g., clobazam, ethosuximide, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • aprepitant
  • aripiprazole
  • atropine
  • azelastine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • baclofen
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • bicalutamide
  • boceprevir
  • bosentan
  • brimonidine
  • bromocriptine
  • bupropion
  • buspirone
  • butorphanol
  • buprenorphine
  • cabergoline
  • calcium channel blockers (e.g., diltiazem, nifedipine,verapamil)
  • celecoxib
  • chloral hydrate
  • chloramphenicol
  • chloroquine
  • cinacalcet
  • cocaine
  • clotrimazole
  • conivaptan
  • cyclobenzaprine
  • cyclosporine
  • deferasirox
  • desmopressin
  • desvenlafaxine
  • dexamethasone
  • dextromethorphan
  • digoxin
  • disopyramide
  • dronedarone
  • enzalutamide
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • flavoxate
  • glycopyrrolate
  • granisetron
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
  • isoniazid
  • ketotifen
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • magnesium sulfate 
  • methotrimeprazine
  • metoclopramide
  • metronidazole
  • mirabegron
  • mirtazapine
  • mitotane
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, phenelzine, selegiline, tranylcypromine)
  • muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • naltrexone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • norfloxacin
  • octreotide
  • olopatadine
  • ondansetron
  • orphenadrine
  • oxybutynin
  • peginterferon Alfa-2b
  • pentazocine
  • perampanel
  • pramipexole
  • quinine
  • quinidine
  • rifabutin
  • rifampin
  • ropinirole
  • rufinamide
  • St. John's wort
  • scopolamine
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • simeprevir
  • tricyclic antidepressants (TCAs; e.g., amitriptyline, clomipramine, desipramine, imipramine)
  • tapentadol
  • telaprevir
  • terbinafine
  • tetracycline
  • ticlopidine
  • tiotropium
  • tocilizumab
  • tolterodine
  • trazodone
  • tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
  • "triptan" migraine medications (e.g., eletriptan, sumatriptan)
  • tryptophan
  • valerian
  • venlafaxine
  • warfarin
  • zolpidem 
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Services in pharmacy are the sole responsibility of pharmacist-owners. Only pharmacists are responsible for pharmacy practice. They only provide related services acting under a pharmacist-owner’s name.